mmr and varicella vaccine in premature infants

Conditions: Chickenpox; Rubella; Rubeola; Mumps

Summary: this research is designed to address the question, "does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" we propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at \<29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.

title: mmr and varicella vaccine responses in extremely premature infants phase: iv population: 16 generally healthy premature infants born at \ /= 37 weeks' gestation, \< 16 months old from the rochester area number of sites: university of rochester study duration: 1.5 - 8.5 months description of agent or intervention: subjects will make 2 study visits. the first, at 15 months of age, will coincide with a routine well child visit. subjects will have 2 ml of blood drawn at the time of their routine, 15-month mmr, varicella, and pneumococcal conjugate immunizations. at a second study visit 4-6 weeks later, another 2 ml of blood will be drawn. objectives: primary: we propose to measure the immunogenicity of routinely administered varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at \<29 weeks gestation (premature), when compared to that in full-term infants. measles titers will be measured by neutralization assay. mumps and rubella titers will be measured by enzyme-linked florescent immunoassay. varicella titers will be measured by enzyme linked immunosorbent assay. safety will be assessed by parental recall of vaccine-related adverse events and by active, prospective collection of blood-draw-associated adverse events. schematic of study design: subjects will be approached at 9-12 months of age for inclusion, and will consent at this time or at visit 1 visit 1 (15 mos): preterm n = 16, full term n = 16, 2 ml blood draw routine mmr, varicella vaccines administered by primary pediatrician per standard of care (at visit 1) visit 2 (16 mos): preterm n = 16, full term n = 16, 2 ml blood draw varicella, mumps, measles and rubella vaccine titers measured by elisa

Eligibility criteria:
inclusion criteria: subjects must meet all of the inclusion criteria to participate in this study. 1. premature infant \ /= 37 weeks' gestation at birth. 2. postnatal age \< 16 months, 0 days. 3. has not yet received mmr or varicella vaccines. (there are no restrictions on the administration of other vaccines at the time of mmr/varicella vaccination.) 4. parental permission. 5. agreement of primary care pediatrician/ health care provider. 6. receives primary pediatric care within an approximate 25-mile radius of the university of rochester. 7. healthy status at enrollment. exclusion criteria: 1. known immunodeficiency. 2. systemic corticosteroid therapy at the time of mmr/varicella vaccination. 3. requiring oxygen therapy. 4. clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion. 5. any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

Keywords: immunization vaccine low birth weight infant premature infant